EPIMix Versus CT Brain Pediatric Study

Brain Diseases Clinical Trial

Official title:

EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847051
• Other study ID #: EPIMix pediatric
• Status: Completed
• Start date: February 15, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.

Description:

The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.

Included patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.

Study participants are in addition to computed tomography investigated during same day at 3T MR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2022
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 4-18 years.

• Patient with suspicion of cerebral pathology.

• Referral to elective brain CT study.

Exclusion Criteria:

• CT planned with sedation

• known previous cerebral pathology (follow up study)

• Emergency CT

• Aborted MR exam

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Diagnostic Test:
• MRI
Brain MRI without intravenous contrast

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	GE Healthcare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of a new fast MR method in children	Number of aborted MR	At 0 hours
Primary	Diagnostic potential	Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale (1 - definitely normal, 2 - Probably normal, 3 - Indeterminate, 4 - Probably abnormal, 5 - Definitely abnormal) compared to abnormal/normal brain CT.	At 0 hours
Secondary	Lesion classification	Classification into disease categories (Neoplastic, Ischemic, Hemorrhagic, Infection, Neuroinflammation, Hydrocephalus, Congenital malformation, Indeterminate)	At 0 hours
Secondary	Lesion location determination	Anatomical localization of abnormality (Cerebrum, Cerebellum, Brainstem, Intraventricular, Subarachnoid space including basal cisterns, Intra-orbital, Skull/Skull base/dural, Other)	At 0 hours
Secondary	Diagnostic imaging quality	Diagnostic imaging quality (5 point Likert scale; 1 - Excellent diagnostic imaging quality, 2 - Good diagnostic imaging quality, 3 - Sufficient diagnostic imaging quality, 4 - Restricted diagnostic imaging quality, 5 - Poor diagnostic imaging quality)	At 0 hours
Secondary	Lesion description	For example effect on brain parenchyma and size	At 0 hours
Secondary	Diagnostic confidence	Five point Likert scale (Very confident, Predominantly confident, Fairly confident, Only slightly confident, Not at all confident)	At 0 hours
Secondary	Clinical diagnostic summary report	Text (one sentence summary of the finding including type of lesion and location)	At 0 hours
Secondary	Ability to rule out diseases	A list of diseases. Number of positive versus negative cases for each investigation (including: Tumor, Abscess, Parenchymal Haemorrhage, Acute Ischemia, Hydrocephalus, Neuroinflammation, Subarachnoid hemorrhage, Extraaxial fluid collection)	At 0 hours
Secondary	Artefacts	Artefacts and impact (Motion, Beam hardening, Other) defined as; Not present, Not affecting diagnostic confidence, Degrading diagnostic confidence)	At 0 hours